New York, December 24, 2014 (GLOBE NEWSWIRE) -- Merck & Co. Ltd. (NASDAQ: MGK), one of the world’s leading pharmaceutical companies, announced today that it has reached an agreement with the U. S. Securities and Exchange Commission (SEC) for the effective termination of a one-time license for its Abbreviated New Drug Application (ANDA) for Zyprexa® (olanzapine).
Abbreviated New Drug Application for Zyprexa is a drug that is indicated for the treatment of schizophrenia and other psychiatric disorders. Zyprexa has been approved for use in the United States since October 2014. The Company’s Abbreviated New Drug Application for Zyprexa is the second of a series of FDA-approved indications that are used to treat schizophrenia, bipolar disorder and mixed mania. It is indicated for the treatment of primary or recurrent major depressive disorder (depression-depressant) and mixed manic or mixed depression.
The Company is committed to patient safety and regulatory compliance. We will continue to monitor the progress of our products and conduct ongoing clinical trials.
About Abbreviated New Drug Application
Abbreviated New Drug Application for Zyprexa is a pharmaceutical product with the active ingredient olanzapine. The product is indicated for the treatment of schizophrenia and other psychiatric disorders.
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Zyprexa® is aripiprazole, also known as olanzapine, is a brand name for the drug Zyprexa, also known as Zyprexa (olanzapine).
Abbreviated New Drug Application for Zyprexa is a prescription drug product. Abbreviated New Drug Application for Zyprexa was developed by the United States Department of Health and Human Services and approved in the United States in 1997 for treatment of schizophrenia. Approval for Zyprexa was granted for the treatment of schizophrenia in the United States and other countries in 2006.
Abbreviated New Drug Application for Zyprexa is a drug for the treatment of the following conditions:
Major depressive disorder and major depressive disorder (MDD), bipolar disorder, and mixed manic or mixed depression.
About FDA-Approved Approval
The Food and Drug Administration (FDA) has granted approval for Abbreviated New Drug Application (ANDA) for Zyprexa in the following categories:
Schizophrenia (SAD):Abbreviated New Drug Application for Zyprexa (olanzapine) for the treatment of schizophrenia. The SAD indication is the treatment of schizophrenia. The drug has not been approved for use in the United States.
About Merck & Co.
Meregens Pharma, Inc. is a global specialty pharmaceutical company. We develop, manufacture and distribute innovative products that help treat a wide range of health care needs. In addition to our products we provide a full range of services to patients across multiple segments of the health care industry, including the medical field, and provide quality, personalized care to the patients and their families.
Merck and its subsidiary company, Merck & Co., Ltd. (NYSE: MGK), which is a major player in the pharmaceutical industry, have agreed to co-extend their rights to Abbreviated New Drug Application (ANDA) for Zyprexa, the only drug approved for this indication. In November 2014, Merck & Co. will complete the licensing and development of Abbreviated New Drug Application for Zyprexa and will become the first of the three companies to file for FDA approval for Zyprexa.
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Generic Zyprexa (generic name: olanzapine) is an antipsychotic medication approved by the Food and Drug Administration (FDA) to treat schizophrenia, bipolar disorder, and other conditions.
Schizophrenia: In clinical trials, olanzapine has shown efficacy in improving symptoms in patients with schizophrenia. It is typically prescribed as a second-line treatment for schizophrenia, although olanzapine may also be used in the off-label use of other antipsychotic medications.
Bipolar Disorder: Olanzapine is also approved for the treatment of bipolar disorder, including manic episodes associated with bipolar I disorder. It is sometimes used off-label to treat bipolar disorder, but it is not typically recommended for use in this setting.
is a brand-name antipsychotic medication approved by the FDA to treat schizophrenia, bipolar disorder, and other conditions. It works by affecting the levels of certain chemicals in the brain. Schizophrenia, Bipolar disorder, and manic episodes associated with bipolar disorder may be treated with olanzapine, but it may also be prescribed off-label for other uses.
Zyprexa (generic name: olanzapine) is a drug that belongs to a class of drugs called atypical antipsychotics. It is an atypical antipsychotic medication that works by altering the levels of certain chemicals in the brain.
Schizophrenia: Olanzapine may also be used off-label for schizophrenia, bipolar disorder, and other conditions.
Bipolar Disorder: Olanzapine may also be used off-label for bipolar disorder, including manic episodes associated with bipolar I disorder. It is sometimes used off-label for bipolar disorder, but it is not typically recommended for use in this setting.
Both schizophrenia and bipolar disorder can cause side effects. Olanzapine can lead to weight gain and metabolic changes, so patients should discuss the risks and benefits with their healthcare provider before starting treatment.
The typical starting dose for schizophrenia and bipolar disorder is 1 to 2 weeks, but patients can see improvement after 2 to 4 weeks. Olanzapine may be started in the first week of therapy, but patients should be monitored for any weight gain or metabolic changes, especially if they have already taken this medication. If a patient stops taking olanzapine, they should not start a second dose.
Zyprexa (generic name: olanzapine) should be taken exactly as prescribed by a healthcare provider, as directed by a healthcare professional. If you are on a fixed dose of olanzapine, you should take it as soon as you feel the effects of the first dose. However, the dosage may be adjusted based on how you react to the medication or how long you plan to take it.
Olanzapine is usually taken once a day with food.
Patients should follow their healthcare provider's instructions about how to take olanzapine as directed and not exceed the prescribed dosage.
Zyprexa can be taken with or without food.
Do not stop taking olanzapine without talking to your healthcare provider first. If you discontinue taking olanzapine, you should stop taking the medication immediately and consult with your healthcare provider.
Patients should not increase their doses of olanzapine without talking to their healthcare provider first. If you are having a heart rhythm problem, your healthcare provider may adjust the dosage or recommend alternative treatment options.
In a market that's been hit by the sudden surge in prescription drug spending, a new study suggests that a drug that had been approved for its uses as a psychiatric drug could be a more profitable alternative.
In a new study released Monday, researchers at the University of California, San Francisco, examined the potential use of the antipsychotic Zyprexa in the treatment of schizophrenia and bipolar disorder.
It was the first time the drug was shown to be effective in treating a specific type of psychiatric disorder, which affects about 2 million Americans.
The new findings suggest that Zyprexa could be a safer alternative to schizophrenia and bipolar disorder treatment, because it could be as effective as a different class of drugs in treating the condition.
"When people take antipsychotic medication, they are taking an antipsychotic medication and the drug may affect their ability to function in a psychiatric state," said lead author Dr. David K. Rosen, a professor of pediatrics and psychiatry at the University of California, San Francisco.
The study, published online Friday in the journal, examined the use of the drug, known as Zyprexa, in more than 1,000 people with schizophrenia and bipolar disorder. The drug was used by about 2 million people in the United States last year and has been shown to be more effective than some other psychiatric medications.
"If someone takes Zyprexa, they may be able to get a better response to treatment," said Rosen, who was not involved in the study.
Zyprexa is known as a long-acting drug and can be prescribed as long as three to five months, depending on the condition being treated.
The study was conducted by the University of California at San Francisco's Department of Medicine's School of Medicine.
It was based on data from the National Institute of Mental Health (NIMH) study of people treated with an antipsychotic drug, including Zyprexa, for about two years.
Schizophrenia is the most common psychotic disorder in the United States, with about one million people suffering from the condition each year. The most common condition is schizophrenia in about 10 percent of the population, but can be serious if the patient is misdiagnosed or if they do not respond to other treatment options.
Schizophrenia is often diagnosed by a doctor's observation and clinical judgment. A doctor may order certain tests to monitor the patient's behavior, and the doctor may prescribe Zyprexa, which can be taken as long as six months. It is available in several forms, including tablets, creams, ointments and eye drops.
Zyprexa can also be prescribed as a mood stabilizer, as a medication to treat insomnia or a sedative. It can be given in the form of tablets, creams, ointments and eye drops, or as an oral medication.
A single Zyprexa tablet should be taken three times a day for at least three days, but can be taken up to eight hours before a scheduled drug treatment.
Schizophrenia patients can have negative symptoms for at least two weeks. Some of the negative symptoms may include mood swings, irritability and difficulty concentrating.
Zyprexa, also known as olanzapine, has been approved by the Food and Drug Administration (FDA) to treat schizophrenia and bipolar disorder.
A study published last week in the Journal of the American Medical Association and the journalPsychopharmacology Todayfound that olanzapine was more effective than a placebo in treating patients with schizophrenia. A meta-analysis published in the April 8 edition ofAmerican Journal of Psychiatryfound that olanzapine was also superior to placebo in treating bipolar disorder.
The researchers compared the effectiveness of Zyprexa to two of the antipsychotic drugs used in the study, risperidone (Risperdal) and olanzapine (Zyprexa), as well as the other antipsychotic drugs, including chlorpromazine (Thorazine), risperidone (Risperdal) and olanzapine (Zyprexa). They found that the olanzapine group was about four times more effective than the risperidone and the chlorpromazine group.
In one trial, the antipsychotic group had a statistically significant improvement in symptoms of schizophrenia compared to the placebo group.
Zyprexa (olanzapine) is a drug approved for the treatment of schizophrenia. It works by helping to restore the balance of certain neurotransmitters in the brain.
Schizophrenia is the most common form of schizophrenia, and is the most severe form of the illness, affecting up to 75% of patients. The condition can be caused by several factors, including:
Zyprexa is used for the short-term treatment of schizophrenia. It can be taken on an empty stomach, with or without food, for up to 12 weeks.
Zyprexa is a medication that can be used in the short-term treatment of schizophrenia, but is not recommended for long-term use. It should be taken once daily, with or without food.
The drug can be prescribed to patients who are at high risk of developing schizophrenia, and it is not recommended for long-term use.
Common side effects of Zyprexa include:
Zyprexa is also used for the treatment of certain mental disorders, such as anxiety, depression, and Parkinson’s disease.
Zyprexa is available in several strengths and forms, including:
Zyprexa can be used for the short-term treatment of schizophrenia, but is not recommended for long-term use.
Zyprexa is available in several forms, including:
Zyprexa can be used to treat certain mental disorders, such as anxiety and depression, but is not recommended for long-term use.
Zyprexa can be used to treat a variety of conditions, including:
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